Part 1：r/r B-cell MalignanciesPhase 1/2NCT04014205
A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies
A Phase 1/2 study testing Orelabrutinib (ICP-022) in people with Part 1：r/r B-cell Malignancies and Part 2：B-cell Malignancies, run by Beijing InnoCare Pharma Tech Co., Ltd. at 36 sites in 4 countries.
Trial summary
This is a Phase I/II, multicenter, open-label study to evaluate the safety, efficacy, tolerability, and pharmacokinetics of a novel BTK inhibitor, Orelabrutinib (ICP-022) in Patients with B-cell malignancies. The study contains two parts, Part 1 (dose escalation) and Part 2 (dose expansion). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Part 1：r/r B-cell Malignancies, Part 2：B-cell Malignancies
- What is being tested?
- Orelabrutinib (ICP-022)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 36 sitesin 4 countries
- Study dates
- 18 Nov 2019to 30 Jun 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent.
- Age ≥ 18 years.
- Part 1: Patients with histologically confirmed relapsed or refractory B-cell malignancies, including Grades 1-3a FL, MZL, MCL, and CLL/SLL.
- Part 2: Patients with histologically confirmed B-cell malignancies including r/r FL, r/r MZL and CLL/SLL with/without prior treatment.
- Life expectancy (in the opinion of the investigator) of ≥ 4 months.
- ECOG performance status of 0 ~1.
- Must have adequate organ function.
- Negative test results for HBV ([HBsAg (-)] and non-active HBV or HCV infection
Who cannot join
- Pregnant or breast-feeding or intending to become pregnant during the study.
- Prior treatment with systemic immunotherapeutic agents.
- Known allergies to Orelabrutinib (ICP-022) or its excipients or infection with HIV.
- Treatment with any chemotherapeutic agent, or any other investigational therapies within 4 weeks prior to first dose of the study drug.
- History of allogeneic stem-cell (or other organ) transplantation or confirmed progressive PML.
- Any external beam radiation therapy within 6 weeks prior to the first dose of the study drug.
Show all 16Show fewer
- Concurrent use of warfarin or other vitamin K antagonists or anticoagulation therapies or strong CYP3A inhibitor.
- Active uncontrolled infections.
- Recent infection requiring IV anti-infective treatment that was completed ≤ 14 days before the first dose of study drug.
- Unresolved toxicities from prior anti-cancer therapy.
- Medically apparent CNS lymphoma or leptomeningeal disease.
- Current or previous history of CNS disease.
- Major surgery or significant traumatic injury < 28 days prior to the first dose of the study drug.
- Patients with another invasive malignancy in the last 2 years.
- Significant cardiovascular disease or active pulmonary disease.
- Received systemic immunosuppressive medications.
Trial locations and contacts
36 sites in 4 countries.
36 sites in 4 countries
United States27 sites
Pacific Cancer Medical Center
Anaheim, California, 92801-1824
Anne Arundel Medical Center (AAMC) Oncology and Hematology
Annapolis, Maryland, 21401-3093
Gabrail Cancer Research Center
Canton, Ohio, 44718
Tennessee Oncology - Chattanooga Oncology & Hematology Associates
Chattanooga, Tennessee, 37404-1130
Northwest Neurology - Rolling Meadows Office
Elk Grove Village, Illinois, 60007
Summit Medical Group
Florham Park, New Jersey, 07932-0001
Florida Cancer Specialists (FCS) South
Fort Myers, Florida, 33901
Goshen Center for Cancer Care
Goshen, Indiana, 46526
MD Anderson Cancer Center
Houston, Texas, 77030
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909-1327
Southeast Nebraska Cancer Center
Lincoln, Nebraska, 68510-2496
Los Angeles Cancer Network - Good Samaritan Hospital Location
Los Angeles, California, 90017
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee, 37203-1625
Tulane University School of Medicine - Tulane Cancer Center Comprehensive Clinic TCCCC
New Orleans, Louisiana, 70112
Mayo Clinic-Mayo Clinic Hospital-Phoenix
Phoenix, Arizona, 85054-4502
University of Pittsburgh - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, 92270
Mayo Clinic - Minnesota
Rochester, Minnesota, 55905-0001
Coborn Cancer Center
Saint Cloud, Minnesota, 56303
Guthrie Cancer Center
Sayre, Pennsylvania, 18840
Orchard Healthcare Research Inc.
Skokie, Illinois, 60077
Medical Oncology Associates PS (dba Summit Cancer Centers)
Spokane, Washington, 99201
Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center)
Topeka, Kansas, 66606
Prairie Lakes Cancer Center
Watertown, South Dakota, 57201
Asclepes Research Centers - Weeki Wachee
Weeki Wachee, Florida, 34607
Clinical Research Alliance
Westbury, New York, 11590
The Oncology Institute of Hope & Innovation
Whittier, California, 90603
Ukraine6 sites
Cherkassy Regional Oncology Center
Cherkasy
Khmelnytskyi Regional Hospital
Khmelnytskyi
St. Luke's Hospital - Medical and Diagnostic Center
Kropyvnytskyi
National Cancer Institute
Kyiv
Institute of Blood Pathology and Transfusion Medicine
Lviv
Transcarpathian Regional Clinical Hospital named after Andrii Novak
Uzhhorod
About this study
Official title: A Phase I/II，Multicenter, Open-Label, Study of a Novel Bruton's Tyrosine Kinase Inhibitor, Orelabrutinib, in Patients With B-Cell Malignancies
This is a Phase I/II, multicenter, open-label study to evaluate the safety, efficacy, tolerability, and pharmacokinetics of a novel BTK inhibitor, Orelabrutinib (ICP-022) in Patients with B-cell malignancies. The study contains two parts, Part 1 (dose escalation) and Part 2 (dose expansion).
- Being tested
- Orelabrutinib (ICP-022)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orelabrutinib (ICP-022)Drug
ICP-022 The drug product is a white, round, uncoated tablet
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Dose Escalation | Experimental | Patients with r/r B-cell malignancies including Grades 1-3a FL, MZL, MCL, and CLL/SLL Receives: Drug: Orelabrutinib (ICP-022) |
| Part 2 Dose Expansion | Experimental | Arm 1: Patients with r/r MCL
Arm 2: Patients with other types of B-cell malignancies, including:
* CLL/SLL with/without prior treatment
* r/r FL
* r/r MZL Receives: Drug: Orelabrutinib (ICP-022) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 Dose Escalation：The maximum tolerated dose (MTD)
To determine the maximum tolerated dose (MTD)
Measured: Incidence of dose limiting toxicities (DLTs) up to 28 days
Part 2 Dose Expansion：ORR
To assess anti-tumor activity of Orelabrutinib (ICP-022) in Patients with B-cell malignancies including r/r MCL, r/r FL, r/r MZL and CLL/SLL with/without prior treatment.
Measured: Up to 2 years
Secondary outcomes (5)
Part 1 Dose Escalation：Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability]
The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of ICP-022 will be assessed
Measured: Up to 2 years
Part 1 Dose Escalation：ORR
Objective response rate
Measured: Up to 2 years
Part 1 Dose Escalation：T1/2
Elimination half-life
Measured: Up to 2 years
Part 2 Dose Expansion：Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability]
The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of ICP-022 will be assessed
Measured: Up to 2 years
Part 2 Dose Expansion：DOR
Duration of response
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start18 Nov 2019
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Part 1：r/r B-cell MalignanciesStudies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014205
- Sponsor's protocol ID
- ICP-CL-00107
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2019
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II，Multicenter, Open-Label, Study of a Novel Bruton's Tyrosine Kinase Inhibitor, Orelabrutinib, in Patients With B-Cell Malignancies
- ClinicalTrials.gov ID
- NCT04014205
- Acronym / sponsor ID
- ICP-CL-00107
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I/II, multicenter, open-label study to evaluate the safety, efficacy, tolerability, and pharmacokinetics of a novel BTK inhibitor, Orelabrutinib (ICP-022) in Patients with B-cell malignancies. The study contains two parts, Part 1 (dose escalation) and Part 2 (dose expansion).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 Dose Escalation | Experimental | Drug: Orelabrutinib (ICP-022)Patients with r/r B-cell malignancies including Grades 1-3a FL, MZL, MCL, and CLL/SLL |
| Part 2 Dose Expansion | Experimental | Drug: Orelabrutinib (ICP-022)Arm 1: Patients with r/r MCL Arm 2: Patients with other types of B-cell malignancies, including: * CLL/SLL with/without prior treatment * r/r FL * r/r MZL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed Informed Consent.
- Age ≥ 18 years.
- Part 1: Patients with histologically confirmed relapsed or refractory B-cell malignancies, including Grades 1-3a FL, MZL, MCL, and CLL/SLL.
- Part 2: Patients with histologically confirmed B-cell malignancies including r/r FL, r/r MZL and CLL/SLL with/without prior treatment.
- Life expectancy (in the opinion of the investigator) of ≥ 4 months.
Key exclusion criteria (16 listed)
- Pregnant or breast-feeding or intending to become pregnant during the study.
- Prior treatment with systemic immunotherapeutic agents.
- Known allergies to Orelabrutinib (ICP-022) or its excipients or infection with HIV.
- Treatment with any chemotherapeutic agent, or any other investigational therapies within 4 weeks prior to first dose of the study drug.
- History of allogeneic stem-cell (or other organ) transplantation or confirmed progressive PML.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orelabrutinib (ICP-022)ICP-022 The drug product is a white, round, uncoated tablet | Drug | Part 1 Dose Escalation, Part 2 Dose Expansion |
Primary outcome
Part 1 Dose Escalation：The maximum tolerated dose (MTD)
Time frame: Incidence of dose limiting toxicities (DLTs) up to 28 days
To determine the maximum tolerated dose (MTD)
Part 2 Dose Expansion：ORR
Time frame: Up to 2 years
To assess anti-tumor activity of Orelabrutinib (ICP-022) in Patients with B-cell malignancies including r/r MCL, r/r FL, r/r MZL and CLL/SLL with/without prior treatment.
5 secondary outcomes
Part 1 Dose Escalation：Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability]
Time frame: Up to 2 years
Part 1 Dose Escalation：ORR
Time frame: Up to 2 years
Part 1 Dose Escalation：T1/2
Time frame: Up to 2 years
Part 2 Dose Expansion：Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability]
Time frame: Up to 2 years
Part 2 Dose Expansion：DOR
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Orelabrutinib (ICP-022) in people with Part 1：r/r B-cell Malignancies and Part 2：B-cell Malignancies, run by Beijing InnoCare Pharma Tech Co., Ltd. at 36 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Ukraine, Israel, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 Dose Escalation：The maximum tolerated dose (MTD) (time frame: Incidence of dose limiting toxicities (DLTs) up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.